Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to collect long-term safety and tolerability data for aficamten (CK-3773274)

Official Title

An Open-Label Study of CK-3773274 for Patients With Symptomatic Hypertrophic Cardiomyopathy (HCM)

Keywords

Symptomatic Hypertrophic Cardiomyopathy (HCM) Obstructive Hypertrophic Cardiomyopathy oHCM CK-3773274 CK-274 Non obstructive hypertrophic cardiomyopathy nHCM HCM Hypertrophic cardiomyopathy Aficamten REDWOOD-OLE CY 6022 Cardiomyopathies Cardiomyopathy, Hypertrophic Hypertrophy

Eligibility

You can join if…

Open to people ages 18-85

  • Completion of a Cytokinetics trial investigating CK-3773274
  • LVEF ≥55% at the Screening Visit

You CAN'T join if...

  • Has taken any investigational study drug other than CK-3773274 within 30 days prior to screening
  • Since completion of a previous trial of CK-3773274 has:
  • Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) <30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) <100 bpm and/or rhythm is stable >30 days
  • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation) since the completion of a prior trial of CK-3773274.
  • Has current obstructive coronary artery disease (>70% stenosis documented in one or more arteries)
  • Has moderate or severe aortic valve stenosis
  • Had a confirmed LVEF <40% with an associated dose interruption during CY 6021
  • History of syncope or sustained ventricular tachyarrhythmia with exercise within 30 days prior to screening
  • History of appropriate ICD shock within 30 days prior to screening
  • Has received treatment with mavacamten

Locations

  • UCSF Medical Center
    San Francisco California 94143 United States
  • Cedars-Sinai Medical Center (Smidt Heart Institute)
    Los Angeles California 90048 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Cytokinetics
ID
NCT04848506
Phase
Phase 2 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated